The Nuts, Bolts and Ethics of Animal Research in the Global Search for Cures
Debunking claims in a February 2023 article about animal research in Japan, the author examines the facts of Japanese and Western biomedical research standards.
On February 18, 2023, the Mainichi Shimbun, English edition, claimed that "live animal testing" in Japan "drags" behind the rest of the world. That world, according to the Mainichi article, means Europe and the United States. The Mainichi article asserted that, in animal research in Japan, animals are "still subject to needless pain and sacrifice." It also asserted that this is a "situation that seems unlikely to change any time soon."
Furthermore, according to the article, Europe and the United States espouse a "widely accepted" concept "of animals' right to life," implying Western moral superiority compared to Japan. Since Japan allegedly has little or no regard for animal welfare, particularly regarding animals used for biomedical research, the Japanese are morally deficient.
Read part one: Beyond the Propaganda, Animal Testing Helps Save Lives
A spokesperson for People for the Ethical Treatment of Animals (PETA) in the article called for a "constructive debate." Yet readers do not see anything resembling a "constructive debate." There were quotes from a middle school student buying "cruelty free" cosmetics and a university veterinarian, who mumbled something about "animal welfare" but did not point out PETA's own pathetic animal welfare record.
What does PETA believe? "Animals are not ours to experiment on, eat, wear, use for entertainment, or abuse in any other way." PETA's leadership has demanded outlawing pet ownership as well as the use of animals in biomedical research.
Based on these stated principles, what is their ultimate goal?
Two Worlds Divided
PETA's goal seems to be a world squarely divided into an animal one and a human one. Yet, how is this likely, given the abundance of both visible and non-visible animals that surround humans every day?
Animal rights groups claim that animals have "rights". What rights are these? Animals, they will state, have a "right to life" and a life "free from pain and suffering." Put humans aside, as they are indeed at the apex of the food pyramid, and will animals experience even less pain and suffering?
Anyone who has seen animals in the wild knows that their lives are far from soft and cushy. Under any circumstance, an adult murdering a child is abhorrent. Adult nonhuman animals do kill and sometimes eat their offspring. Have animal "rights" groups filed murder charges against adult animals on behalf of murdered offspring?
Given that the Mainichi Shimbun neglected to elaborate what PETA has in mind for humankind, what are readers to make of the other claims in its article?
Broad Claims Ignoring the Status in Japan
The Mainichi made a broad claim that Europeans and Americans "widely accept" "animals' right to life" and "a number of companies" have "stated their opposition" to the use of animals in "research and development of cosmetics and medical products." However, it failed to point out that, in Japan as well as in the US, regulators review safety data before cosmetics and pharmaceuticals are allowed to be sold.
With respect to cosmetics, US regulators have allowed not only safety data obtained from living animals (in vivo) but also previous data for previously approved compounds and safety data obtained from tissue culture (in vitro) and from computer simulations (in silico). Thereby, they allow replacing and reducing the use of laboratory animals.
In Japan, too, both the Japan Cosmetic Industry Association and the Ministry of Health, Labor and Welfare have sought greater use of in silico and in vitro methods to obtain mandated safety data. The Mainichi casts aspersions upon the Japanese, but the Japanese, like Westerners, do appreciate an animal's "right to life."
Most Japanese readily perceive the necessity of biomedical studies utilizing animals according to a 2019 poll of Japanese peoples' attitudes towards the use of animals for biomedical research. At the same time, many express "pity" for experimental animals and concern for pain during procedures.
Most Japanese back improvements in laboratory animal welfare and greater disclosure from scientists concerning the purpose of their biomedical studies. At the same time, only a small minority are interested in supporting a "social movement for abolition and reduction of animal experiments."
Thus, the Japanese are more than eager to learn more and, unlike Westerners, not easily swayed by emotional platitudes.
The Basis of Universal Principles
Revelations of German physicians performing inhumane experiments on people without their consent during the Nazi era led to the creation of a written 10-point guideline for ethical human clinical studies. Some points include obtaining informed, voluntary consent prior to study initiation, clear study objectives and the avoidance of "unnecessary physical and mental suffering and injury."
Highly relevant is point number three: "The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment."
The use of animals for scientific purposes is neither a luxury nor frivolous ー it is necessary.
The nuts and bolts of laboratory animal welfare varies across the European Union, United States and Japan. But all are based on the universal principle of the "3R's": replacement, reduction, and refinement. Respectively, those mean identifying potentially suitable alternatives for live animals, using the least number of animals without compromising study validity, and improving upon current methods to minimize pain and distress.
A Look at the 'Nuts and Bolts' in the EU
The level of government involvement varies across countries as well. In turn, that affects the content and operation of laboratory animal welfare programs within each country.
On one hand, studies in the EU involving animals are regulated at multiple levels by law. The institution, including universities and companies in which studies are conducted, individual researchers and animal study protocols must be authorized by government agencies.
An EU Directive spells out requirements for the care and housing of laboratory animals, from amphibians, birds, and rodents to nonhuman primates and large domesticated animals. Institutions that use animals for scientific purposes are required to have an in-house animal welfare body that oversees the institution's laboratory animal care and use program.
Ultimately, the EU aims to end "all animal research" and replace it with "non-animal methods of research."
'Nuts and Bolts' in the US and Japan
In the United States, the use of laboratory animals is regulated at the institutional level. Institutions that receive federal funds are covered by the Animal Welfare Act, which includes specifications on housing, sufficient and documented veterinary care and pre-review of study plans involving laboratory animals.
While individuals and laboratory groups do not face EU-style licensing in the US, institutions must document that animal care and use staff (including visiting scientists, students and heads of labs) are trained and knowledgeable not only in their specific tasks related to animal use but also in the principles of laboratory animal welfare.
Government agencies can and do inspect institutions and their laboratory animal welfare programs for compliance in both the EU and the US. In addition, there are non-governmental animal welfare organizations that do the same, following local laws and official guidelines.
Japan offers a unique approach in regulating laboratory animal welfare. That is to place the burden on individuals involved in the care and use of laboratory animals. While Japan does have laws and official guidelines regarding the humane use of laboratory animals, they are not as onerous as those of the EU and US.
Indeed, the role of the state in regulating laboratory animal welfare greatly varies between China, South Korea and Japan. Institutions and individuals in Japan could conceivably set up their own laboratory animal welfare standards. However, with the assistance of national professional associations, such as the Japanese Association for Laboratory Animal Science, veterinarian groups, such as the Japanese College of Laboratory Animal Medicine, and international organizations, Japanese institutions can benchmark their laboratory animal welfare programs against those of the EU and US.
Contrary to the Mainichi's claims, Japanese institutions do not "drag" behind Western institutions.
Importance of an Informed Public
The poll mentioned earlier demonstrating substantial acceptance of the use of animals for scientific purposes by the Japanese public also showed a sizable number of those who are undecided, neither for nor opposed. Thus, professional and veterinarian associations in Japan should increase their efforts to clearly elaborate the importance of animals for scientific purposes and that laboratory animal welfare standards in Japan match, or even exceed, those of the West.
Furthermore, it should be pointed out that Japanese commitment to laboratory animal welfare is motivated not by mandates, but by a robust personal conviction.
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Author: Aldric Hama, PhD
Find other reports and analysis by Dr Hama here, on JAPAN Forward.
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